The Australian Clinical Trials Alliance (ACTA) welcomes the opportunity to respond to the Parliamentary Inquiry into approval processes for new drugs and novel medical technologies in Australia.

The inquiry is considering four topics so that Australia continues to be well-positioned to access new drugs and novel medical technologies in a timely manner and respond to emerging global trends.

In the submission, ACTA put forward the following recommendations in response terms of reference 2-4:

Our key recommendations support the overarching objective of making Australia a more attractive location for clinical trials for new drugs and novel medical technologies and ensuring that Australia continues to be well-positioned to access new drugs and novel medical technologies in a timely manner and respond to emerging global trends.

• Recommendation 1: Further increase funding to Clinical Trial Networks (CTNs) to ensure core infrastructure support so that CTNs can operate optimally to address not only the investigator-initiated questions but also develop mechanisms to liaise with industry.
  
  
• Recommendation 2: Enable pathways for the optimal utilisation of CTNs by promoting that new drugs and novel medical technologies are provided to CTNs.
  
  
• Recommendation 3: Increase the amount of funding available to investigator-led clinical trials, which will allow the sector to address conditions where there is an unmet need, in particular orphan, personalised drugs and off-patent that could be repurposed and used to treat new conditions.
  
  
• Recommendation 4: Establish a rigorous pathway for treatments, services and technologies that are unproven in the real world to enter practice as quickly as possible through a conditional scheme.  This scheme would require participation in either a trial conducted by a Clinical Trial Networks (CTNs) and/or Clinical Quality Registries (CQRs) capable of generating important real-world data about the clinical effectiveness and value of the intervention in the real-world context. We believe that this would enable the Government to acquire more data, enhance patient access and enable doctors to gain invaluable experience with new drugs and medical technologies. Such an arrangement would enable Australian healthcare to be evidence-based as well as self-learning.
  
  
• Recommendation 5: Conduct a review of potential reforms to the Medicare Benefits Schedule (MBS), aimed at facilitating the better generation of real-world evidence to improve outcomes and deliver value gains.  The review should consider ways to use savings generated through investigator-initiated trials (IITs) and CQRs as a means of funding these activities.
  
  
• Recommendation 6: Expand the current Parliamentary Inquiry to include all medical interventions, including tests, procedures, devices and new drugs.

The full submission can be downloaded below.